Purpose Coronavirus disease 2019 (COVID-19) has highlighted the need for new methods of pharmacovigilance. Here, we use adult community volunteers to obtain systematic information on vaccine effectiveness and the nature and severity of breakthrough infections. Methods Between December 15, 2020 and September 16, 2021, 11,826 unpaid community-based volunteers reported the following information to an on-line registry: COVID-19 test results, vaccination (Pfizer, Moderna, or Johnson & Johnson) and COVID-19 symptoms. COVID-19 infections were described based on vaccination status at the time of infection: 1) fully vaccinated, 2) partially vaccinated (received first of two-dose vaccines or were <14 days post-final dose), or 3) unvaccinated. Results Among 8554 participants who received any COVID-19 vaccine, COVID-19 infections were reported by 74 (1.0%) of those who were fully vaccinated and 198 (2.3%) of those who were partially vaccinated at the time of infection. Among the 74 participants who reported a breakthrough infection after full vaccination, the median time from vaccination to reported positive test result was 104.5 days (interquartile range: 77–135 days), with no difference among vaccine manufacturers. One quarter (25.7%) of breakthrough infections in the fully vaccinated cases were asymptomatic and most (>97%) fully vaccinated participants reported no symptoms or only mild symptoms compared to 89.3% of the unvaccinated cases. Only 1.4% of fully vaccinated participants reported experiencing at least 3 moderate-to-severe symptoms compared to 7.8% in the unvaccinated. Conclusion Person-generated health data, also referred to as patient-reported outcomes, is a useful approach for quantifying breakthrough infections and their severity and for comparing vaccines. Trial Registration Clinicaltrials.gov NCT04368065, EU PAS Register EUPAS36240.

ObjectiveTo describe cognitive symptoms in people not hospitalised at study enrolment for SARS-CoV-2 infection and associated demographics, medical history, other neuropsychiatric symptoms and SARS-CoV-2 vaccination.DesignLongitudinal observational study.SettingDirect-to-participant registry with community-based recruitment via email and social media including Google, Facebook and Reddit, targeting adult US residents. Demographics, medical history, COVID-19-like symptoms, tests and vaccinations were collected through enrolment and follow-up surveys.ParticipantsParticipants who reported positive COVID-19 test results between 15 December 2020 and 13 December 2021. Those with cognitive symptoms were compared with those not reporting such symptoms.Main outcome measureSelf-reported cognitive symptoms (defined as ‘feeling disoriented or having trouble thinking’ from listed options or related written-in symptoms)ResultsOf 3908 participants with a positive COVID-19 test result, 1014 (25.9%) reported cognitive symptoms at any time point during enrolment or follow-up, with approximately half reporting moderate/severe symptoms. Cognitive symptoms were associated with other neuropsychiatric symptoms, including dysgeusia, anosmia, trouble waking up, insomnia, headache, anxiety and depression. In multivariate analyses, female sex (OR, 95% CI): 1.7 (1.3 to 2.2), age (40–49 years (OR: 1.5 (1.2–1.9) compared with 18–29 years), history of autoimmune disease (OR: 1.5 (1.2–2.1)), lung disease (OR: 1.7 (1.3–2.2)) and depression (OR: 1.4 (1.1–1.7)) were associated with cognitive symptoms. Conversely, black race (OR: 0.6 (0.5–0.9)) and COVID-19 vaccination before infection (OR: 0.6 (0.4–0.7)) were associated with reduced occurrence of cognitive symptoms.ConclusionsIn this study, cognitive symptoms among COVID-19-positive participants were associated with female gender, age, autoimmune disorders, lung disease and depression. Vaccination and black race were associated with lower occurrence of cognitive symptoms. A constellation of neuropsychiatric and psychological symptoms occurred with cognitive symptoms. Our findings suggest COVID-19’s full health and economic burden may be underestimated.Trial registration numberNCT04368065.

BACKGROUND This exploratory study compares COVID-19 vaccine side effects and breakthrough infections in diabetics and non-diabetics using patient-reported data and pharmacy claims. OBJECTIVE The study aims to use patient reported data to evaluate differences in COVID-19 vaccine side effects between diabetic and non-diabetic adults. METHODS Adults who voluntarily self-enrolled between March 19, 2021 and July 16, 2022 in the IQVIA COVID-19 Active Research Experience (CARE) project reported clinical and demographic information, COVID-19 vaccination, test-confirmed infection(s), and consented to linkage with prescription claims which was used for sensitivity analysis of medication effects. RESULTS Diabetics (n=724) reported experiencing fewer vaccine side effects within 2 weeks of vaccination than non-diabetics (n=6,417) (mean [SD]=2.7(2.0] vs. 3.1[2.0]). Adjusted risk of having any or individual side effects was lower among diabetics, with significant reductions in fatigue and headache, but no differences in breakthrough infections over participants’ maximum follow-up time. Diabetic medication use did not consistently affect the risk of specific side effects. CONCLUSIONS Diabetics reported fewer vaccine side effects than non-diabetics, with similar risk of breakthrough infection.

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